Regulatory Affairs Director, Software & Digital Health at Vontive

Deerfield, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, Digital Health, Kidney CareIndustries

Requirements

Minimum of 10 years’ experience with increasing responsibilities in global regulatory affairs and compliance
At least five (5) years in a senior role, interacting with regulatory agencies and other stakeholders

Responsibilities

Develop regulatory strategies designed to expedite global international approvals of digital products
Develop regulatory policies and procedures for assessing and managing digital products, including those with artificial intelligence / machine learning
Act as Regulatory Subject Matter Expert on digital, cybersecurity, and artificial intelligence for Vantive
Represent Vantive externally on standard committees and industry working groups focused on digital, AI and cybersecurity
Lead community of practice for Vantive’s regulatory staff who support digital products
Partner with cross-functional leaders supporting Vantive’s digital portfolio
Identify new regulatory requirements and implement compliance strategies
Manage key regulatory consultants for digital programs
Develop and maintain training curriculum to upskill organization related to digital product requirements
Assess current projects, programs, and competencies to strengthen the organization’s digital acumen; continuously improve cross-organizational cooperation with IT, research and marketing functions
Support regulatory strategies for new digital product development
Advise on changes which may require RA submissions
Represent Vantive and present at software, cybersecurity and digital health conferences
Participate in business development activities related to digital products
Establish policies and procedures governing regulatory activities for Vantive’s digital portfolio
Maintain the company’s compliance to software and cybersecurity requirements related to products

Skills

Key technologies and capabilities for this role

Regulatory AffairsDigital HealthSoftware ComplianceCybersecurityMedical DevicesFDA RegulationsPolicy DevelopmentProcedures Establishment

Questions & Answers

Common questions about this position

What is the work arrangement or location for this role?

This information is not specified in the job description.

What are the key responsibilities of the Regulatory Affairs Director?

The role involves developing regulatory strategies for global approvals of digital products, creating policies for digital products including AI/ML, acting as SME on digital, cybersecurity, and AI, representing Vantive externally, leading a community of practice, and partnering cross-functionally.

What is the company culture like at Vantive?

Vantive fosters a community of focused, courageous people who don't settle for mediocre and are driven to improve patients' lives worldwide through digital innovation in vital organ therapies.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What makes a strong candidate for this Regulatory Affairs Director role?

A strong candidate should be a regulatory subject matter expert and thought leader in digital health, software, cybersecurity, and AI/ML, with experience establishing policies, representing externally, and leading cross-functional teams indirectly.

Vontive

Provides investment property mortgage solutions

About Vontive

Vontive provides investment property mortgages using technology to simplify and speed up the loan process. Their main product is a "bolt-on" technology that allows retail brands to easily launch their own mortgage services without needing programming skills. This no-code solution can be set up in just a few weeks, making it quicker for brands to offer mortgages. Vontive stands out from competitors by acting as a bridge between real estate investors, lenders, and capital providers, charging fees for their services that reduce traditional risks and inefficiencies in real estate financing. The company's goal is to modernize the investment real estate market by making the mortgage process more efficient and transparent for both retail brands and financial institutions.

San Francisco, CaliforniaHeadquarters

2017Year Founded

$32.1MTotal Funding

DEBTCompany Stage

Financial Services, Real EstateIndustries

11-50Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Parental Leave

Short- and Long-term Disability Coverage

Life Insurance

Wellness Program

Risks

Increased competition from fintech companies could erode Vontive's market share.

Potential regulatory scrutiny may lead to higher compliance costs and challenges.

Economic downturns could impact demand for investment property mortgages.

Differentiation

Vontive offers a no-code, white-label mortgage solution for real estate investors.

The platform integrates financial institutions through a unique debt marketplace.

Founded by industry veterans, Vontive leverages decades of mortgage and financial expertise.

Upsides

Vontive ranked #10 on the 2022 Deloitte Technology Fast 500 with 9,154% growth.

The company has financed over $1.1 billion in residential properties since April 2022.

Vontive's B2C ecosystem reaches over 1.5 million real estate investors.

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